DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 October 2025 has been entered in light of the RCE filed 13 November 2025.
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Claim 1 was amended to recite a stopper covering to the port to form a first seal between the cavity and the detector in the first state and to transition to a second state to form a second seal between the enclosure and an external environment when the detector is removed from the port.
Applicant argues Strauss’595’s enclosure is not sealed when does not form a seal when element 8 is removed from the opening. This argument is persuasive. However, upon further consideration, a new, secondary reference, Berry’775 is relied on to render this limitation obvious. See the updated rejection below.
Further, the newly recited limitations are not supported by the specification and raise new issues under 35 USC 112(a). See the rejections below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sleeve and bellows recited in claims 3, 6, 7, 21 and 22 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-9, 11-14, 16-22 are is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to recite “the stopper is further configured to transition from the first state to a second state to form a second pressure-tight seal between the enclosure and an external environment outside of the cavity when the distal portion of the detector device is removed from the port”. Applicant points to paragraphs [0066] and [0096]-[0097] for support.
The specification does not disclose the stopper forms a seal between the detector device and the cavity. The specification discloses there can be a seal or valve between a detector device (“instrument”, paragraph [0066]) and the port. But there is no disclosure that the seal/valve is a stopper or that the seal/valve changes from a first to a second configuration when the detector device is removed from the port.
The specification discloses the stopper can be made of a pliable material at paragraph [0067], but does not disclose that the stopper transitions from a first state to a second state when the detector is removed from the port. Further, the specification does not disclose a valve/seal that changes from a first configuration to a second configuration upon removal of the tool from the valve/seal.
The specification discloses a valve or sealing interface between the instrument (i.e. the claimed detector) and the port at paragraph [0096]. The specification discloses the stopper can form a seal in the port at paragraph [0066]. However, the specification makes no mention of a stopper that forms a first seal between the cavity and the detector, as recited in the claims. The specification does not disclose a valve/seal that changes from a first configuration to a second configuration upon removal of the tool from the valve/seal.
Claim 8 is rejected for similar reasons as claim 1. Specifically, the specification does not disclose a stopper that transitions to form a seal between the enclosure and the external environment when the detector is removed from the port. The specification does not disclose passing an instrument through a stopper or removing an instrument from the stopper. Further, there is no disclosure of a stopper that transitions to a second state.
Claim 2 recites the stopper is a thin membrane covering the port. Claim 3, which depends from claim 2, recites the stopper includes a sleeve or a bellows. The specification does not disclose a thin membrane that includes a sleeve or a bellows, as required by claim 3. Paragraph [0066] discloses the sealing interface between the instrument and the port can include one or more of a membrane, sleeve or bellows. But none of these structures are associated with the stopper in the specification. Further, it is unclear how a sleeve/bellows would be combined with a thin membrane. There is no disclosure of such a structure.
Claims 6 and 7 are rejected for the same reasons as claim 3.
Claim 11 recites a step of placing a pressure sensor against the stopper. There is no disclosure of this step in the specification
Claim 13 recites a step of locating the detector in the stopper. As discussed above with respect to claim 1, There is no disclosure of an instrument passing through the stopper or being removed from the stopper. Further, there is no disclosure of a stopper in the form of a sleeve, membrane or bellows, as recited in claim 13. Paragraph [0066] discloses the sealing interface between the instrument and the port can include one or more of a membrane, sleeve or bellows. But none of these structures are associated with the stopper in the specification.
Claims 21 and 22 recite placing the detector device in the port covered by the stopper. There is no disclosure of passing a tool through the stopper.
Any claim not specifically addressed is rejected by its dependency from a rejected.
Claim Objections
Applicant is advised that should claim 21 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 8-9, 11-14, 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (US Patent 4,907,595) in view of Berry et al. ((US Patent Publication 2010/0298775).
Claim 1: Strauss’595 teaches an apparatus (Figure 1) for use in diagnosing or treating an eye condition of a patient eye using a detector device (5; column 1, lines 10-15), the apparatus comprising:
an enclosure (1), configured to be seated over the eye to form a cavity to define a cavity environment over the eye (Figure 2); and
a port (opening in enclosure 1 which accepts removable element 8 – column 2, lines 56-61), located on a surface of the enclosure (Figure 1), configured to receive a distal portion of the detector device (4, 5, 8) within the port and including a seal to form a pressure-tight seal between the enclosure and a portion of the detector device when the distal portion of the detector device is at least partially inserted through the port into the cavity (column 2, lines 27-32 discloses increasing the gas pressure within the enclosure to increase the pressure, this shows the opening which accepts element 8 is sealable) to allow the distal portion of the detector device (distal end of 5) to be placed in direct or indirect contact with proximity to the eye (Figure 1; column 2, lines 16-20),
wherein the detector device is configured to sense at least one of an indication of the eye or an indication of the cavity environment over the eye column 1, lines 59-65).
Strauss’595 does not disclose the port has a stopper that transitions from a first state to a second state to maintain a seal between the enclosure and the external environment when the detector device is removed from the port.
The concept of maintaining pressure within an enclosed area during surgery is well known. For example, during laparoscopic surgery, the abdominal cavity is filled with air and surgery is performed through a cannula inserted into the abdominal wall. Cannulas often have a sealed opening to allow for the insertion and removal of instruments while preventing air from escaping during surgery.
Berry’775 teaches a cannula (100) that is inserted into the body for use during laparoscopic surgery. The body cavity is insufflated with air and instruments are inserted into the body via the cannula (100) (paragraph [0005]). Like Strauss’595, the cannula (100) has a port (opening 106) through which an instrument is inserted. The port is provided with a stopper (valve 108) covering the port (106) to form a pressure tight seal between the cavity (inside of the body) and an instrument passing through the port (paragraph [0019]). The stopper (108) is configured to transform to a second state to form a second pressure-tight seal between the cavity (inside of the body) and an external environment outside of the cavity when the distal portion of the instrument is removed from the port (paragraph [0019] teaches the valve 108 moves into the closed position when the instrument is removed to prevent insufflation gas from passing through the port).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Strauss’995 with a stopper (i.e. a valve), as taught by Berry’775, in order to allow the user to maintain a pressure within the cavity when the instrument is removed. This will be advantageous to maintain a sterile environment around the eye.
Claim 2, 3, 6: Berry’775 teaches the stopper (valve 108) is a thin membrane covering the port in the form of a sleeve (duckbill valve; paragraph [0019] and Figure 3).
Claim 4: Strauss’595 teaches the detector device includes at least one of a pressure sensor (4 is connected to manometer 6) to sense an indication of fluid pressure in the cavity.
Claim 5: Berry’775 teaches the stopper (valve 108) is sized and shaped to occlude the port (106) (Figure 3; paragraph [0019]) and is configured to separate the cavity (inside of the body) from a surrounding environment (paragraph [0019]).
Claim 8: Strauss’595 teaches a method of using an apparatus (Figure 1), the apparatus including an enclosure (1), configured to be seated over a patient eye to define a cavity over the eye (Figure 2), and a port (opening in enclosure 1 which accepts removable element 8 – column 2, lines 56-61) located on a surface of the enclosure (Figure 1), configured to receive a distal portion of a detector device (5, 8) and including a seal to form a pressure-tight seal between the enclosure and the detector device when the distal portion of the detector device is at least partially inserted through the port (column 2, lines 27-32 discloses increasing the gas pressure within the enclosure to increase the pressure, this shows the opening which accepts element 8 is sealable), the method comprising:
locating the enclosure over the patient eye (Figure 2); and
sensing at least one of an indication of an eye characteristic or an indication of an environment in the cavity when the distal portion of the detector device is at least partially inserted through the port to allow the distal portion of the detector device (at 5) to be placed in direct or indirect contact with proximity to the patient eye (column 3, lines 31-49).
Strauss’595 does not disclose the port has a stopper that transitions from a first state to a second state to maintain a seal between the enclosure and the external environment when the detector device is removed from the port.
The concept of maintaining pressure within an enclosed area during surgery is well known during laparoscopic surgery. During laparoscopic surgery, the abdominal cavity is filled with air and surgery is performed through a cannula inserted into the abdomen wall. Cannulas often have a sealed opening to allow for the insertion and removal of instruments while preventing air from escaping during surgery.
For example, Berry’775 teaches a cannula (100) that is inserted into the body for use during laparoscopic surgery. The body cavity is insufflated with air and instruments are inserted into the body via the cannula (100) (paragraph [0005]). Like Strauss’595, the cannula (100) has a port (opening 106) through which an instrument is inserted. The port is provided with a stopper (valve 108) covering the port (106) to form a pressure tight seal between the cavity (inside of the body) and an instrument passing through the port (paragraph [0019]). The stopper (108) is configured to transform to a second state to form a second pressure-tight seal between the cavity (inside of the body) and an external environment outside of the cavity when the distal portion of the instrument is removed from the port (paragraph [0019] teaches the valve 108 moves into the closed position when the instrument is removed to prevent insufflation gas from passing through the port).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Strauss’995 with a stopper (i.e. a valve), as taught by Berry’775, in order to allow the user to maintain a pressure within the cavity when the instrument is removed. This will be advantageous maintain a sterile environment around the eye.
Claim 9: Strauss’595 teaches the sensing includes sensing an indication of the cavity environment with a pressure sensor (4, 6; column 2, lines 5-7).
Claim 11: Strauss’595 teaches the pressure sensor (4, 6) is located within the port (1), but does not teach the pressure sensor (4, 6) is located against the stopper.
As discussed in the rejection to claim 1, Berry’775 teaches the use of a valve (108) over a port and inserting an instrument through the port such that it is surrounded by the stopper to prevent air from entering or leaving the cavity.
In the resulting device of Strauss’595 in view of Berry’775, the instrument is passed through the stopper (ie valve 108) in to access the cavity. Passing through the valve will include being located against the valve (see Figure 4 of Berry, for example).
Claim 12: Strauss’595 teaches sensing includes sensing an indication of an eye characteristic with the detector device (5 is used to detect perfusion pressure and flow direction in the ophthalmic artery; column 3, lines 33-49).
Claim 13: Strauss’595 teaches sensing an indication of an eye characteristic includes locating at least a portion of the detector device (5, 8) in the port (opening 1) to create a seal between the enclosure and allowing the distal portion of the detector to be placed in direct or indirect contact with the eye (column 3, lines 31-49).
Strauss’595 does not teach a stopper includes a sleeve, membrane or bellows. Berry’775 renders the use of a stopper as obvious – see the rejection to claim 8 above.
Berry’775 further teaches the stopper (valve 108) includes a membrane or sleeve (duckbill valve; paragraph [0019] and Figure 3).
Claim 14: Strauss’595 teaches locating a portion of the detector device (5, 8) in the port (1), but does not teach locating the detector device in the stopper.
Berry’775 renders the use of a stopper (ie valve 108) as obvious – see the rejection to claim 8 above. Berry’775 teaches passing an instrument through the stopper (Figure 4) to maintain insufflation gas within the body cavity during surgery so that gas does not escape around the instrument.
Claim 17: Strauss’595 teaches applying a positive pressure to the cavity with a pressure source (P via element 4) (column 3, lines 37-42).
Claim 18: Strauss’595 teaches processing an indication of an eye characteristic with control circuitry (D, column 3, lines 19-25).
Claim 19: Strauss’595 teaches processing includes adjusting a pressure source to apply pressure to the cavity based at least in part on the indication of an eye characteristic (column 3, lines 37-49).
Claim 20: Strauss’595 teaches adjusting the pressure towards a target value of the eye characteristic (the pressure is increased until flow through the artery is stopped; this flow stoppage is considered a target value).
Claim 21: Strauss’595 teaches placing the detector device (5, 8) in the port (1), but does not teach the port is covered by a stopper. Berry’775 renders the use of a stopper (ie valve 108) as obvious – see the rejection to claim 8 above. The stopper (valve 8) forms a seal between the instrument and the cavity with the sleeve (i.e. duckbill valve 108; paragraph [0019]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Strauss’595 in view of Berry’775, as applied to claim 15, further in view of Berdahl et al. (US Patent 2013/0238015).
Claim 16: Strauss’595, as modified, teaches the limitations of claim 16 except for applying a negative pressure to the cavity.
Like Strauss’595, Berdahl’015 is directed towards an enclosure (120) for placement over the eye (Figure 2) which interfaces with a detector device (“a signal sent from another sensor monitoring the patient’s IOP and/or CSF pressure…”, paragraph [0028]). Like Strauss’595, the enclosure is configured to modify the pressure applied to the eye (paragraph [0028]). Berdahl’015 further teaches increasing or decreasing the pressure in the enclosure relative to atmospheric pressure in order to treat an eye condition (e.g. glaucoma or papilledema).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Strauss’595 to further modify the pressure in the enclosure to be a negative pressure (i.e. below atmospheric pressure), as taught by Berhdal’015, in order to provide treatment to the patient in addition to monitoring.
Claims 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss’595 in view of Berry’775, as applied to claims 3 and 13, further in view of Hueil (US Patent Publication 2005/0077689).
Claims 7: Strauss’595 in view of Berry’775 fail to teach the stopper is a bellows.
As discussed in the rejections to claims 1 and 13, Berry’775 renders it obvious to use a valve to maintain the pressure within a cavity when an instrument is removed through the valve. Similar to Berry’775, Hueil’689 teaches a cannula (10) with an opening (unlabeled but clearly shown near element 14 in Figure 1) for receiving an instrument such that the opening has a valve (30). Hueil689 further teaches providing the valve (30) with a bellows (90) used for radial seal movement (paragraph [0062]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Straus’595 in view of Berry’775 such that the stopper (i.e. Berry’775’s valve) has a bellows, as taught by Hueil’689, in order to allow radial seal movement.
Claim 22: Strauss’595 teaches placing the detector device (5, 8) in the port (1), but does not teach the port is covered by a stopper. Berry’775 renders the use of a stopper (ie valve 108) as obvious – see the rejection to claim 8 above. The stopper (valve 8) forms a seal between the instrument and the cavity with the sleeve (i.e. duckbill valve 108; paragraph [0019]). Hueil’689 teaches the use of a bellows. See the rejection to claim 7 above.
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 1 June 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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